FDA.reportPublic FDA data

MONAT Be Clarified Acne Gel-Cream Cleanser

Manufacturer
MONAT GLOBAL CORP | Oxygen Development
Effective date
2024-12-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:42:13

Label at a glance#

ProductACNE CLEANSER
Active ingredientSALICYLIC ACID
Label structure9 sections

Dosage and administration

Directions Shake well before use Start with damp skin Apply small amount onto your fingertips and emulsify Gently cleanse the skin using circular motions. Rinse with warm water and gently pat the skin dry Follow with your MONAT skincare Routine

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Salicylic Acid 2.00%

OTC - PURPOSE SECTION

Purpose

Acne Treatment

INDICATIONS & USAGE SECTION

Uses

  • For the treatment of acne
  • Helps prevent new acne blemishes from forming

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product

  • skin irritation and dryness are more likely to occur if you use another topicalk acne medication at the same time. If irriatation occurs, only use one topical acne treatment at a time.
  • Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center right immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

  • Shake well before use
  • Start with damp skin
  • Apply small amount onto your fingertips and emulsify
  • Gently cleanse the skin using circular motions.
  • Rinse with warm water and gently pat the skin dry
  • Follow with your MONAT skincare Routine

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Water, Sodium Cocoyl Glutamate, Propanediol, Sorbeth-230 Tetraoleate, Cocamidopropyl Betaine, Sodium C14-16 Olefin Sulfonate, Sodium Cocoyl Isethionate, PEG-120 Methyl Glucose Dioleate, Niacinamide, Cocamide MIPA, Glycerin, Coconut Acid, Sodium Isethionate, Sodium PCA, Maclura Cochinchinensis Leaf Prenylflavonoids, Glycol Distearate, Laureth-4, Sodium Chloride, Sodium Benzoate, Potassium Sorbate, Polyquaternium-10, Decyl Glucoside, Sorbitan Laurate, Isopropyl Alcohol.

Questions or Comments

OTC - QUESTIONS SECTION

Questions or comments?

Toll-free number 1-800-878-1978

PRIMARY PACKAGE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Primary PackagePrimary Package

OUTER PACKAGE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer packageOuter packageSECONDARY-OUTER PACKAGE

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78518-011ACNE CLEANSER (SALYCILIC ACID) GEL [MONAT GLOBAL CORP]2Unmatched20250119_f54d0bad-65cd-4281-e053-2a95a90a9e52.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78518-01178518-011-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
LAURETH-46HQ855798JIACT
SODIUM ISETHIONATE3R36J71C17IACT
GLYCERINPDC6A3C0OXIACT
SALICYLIC ACIDO414PZ4LPZACTIB
WATER059QF0KO0RIACT
SODIUM COCOYL GLUTAMATEBMT4RCZ3HGIACT
PROPANEDIOL5965N8W85TIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
GLYCOL DISTEARATE13W7MDN21WIACT
DECYL GLUCOSIDE, .ALPHA.-47YY6O286HIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
COCONUT ACID40U37V505DIACT
NIACINAMIDE25X51I8RD4IACT
SODIUM COCOYL ISETHIONATE518XTE8493IACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
PEG-120 METHYL GLUCOSE DIOLEATEYM0K64F20VIACT
POLYQUATERNIUM-10 (400 CPS AT 2%)HB1401PQFSIACT
SODIUM CHLORIDE451W47IQ8XIACT
MACLURA COCHINCHINENSIS WHOLEX083FY34PHIACT
ISOPROPYL ALCOHOLND2M416302IACT
SORBITAN MONOLAURATE6W9PS8B71JIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
COCO MONOISOPROPANOLAMIDE21X4Y0VTB1IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
46e07904-3bb9-239b-e063-6294a90ac23ff54d0bad-65cd-4281-e053-2a95a90a9e522025-12-26WarningsExact identifier
spl set id: f54d0bad-65cd-4281-e053-2a95a90a9e52

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.